1. Field of the Invention
The present invention is directed to devices and methods that enable inflatable intragastric balloons used for the treatment of obesity to be filled, and in particular to devices and methods that enable the intragastric balloon to be filled, adjusted, or deflated while the device itself is in the stomach.
2. Description of the Related Art
Intragastric balloons are well known in the art as a means for weight loss and treating obesity. One such inflatable intragastric balloon is described in U.S. Pat. No. 5,084,061 and is commercially available as the BioEnterics Intragastric Balloon System (sold under the trademark BIB®). These devices are designed to provide therapy for moderately obese individuals who need to shed pounds in preparation for surgery, or as part of a dietary or behavioral modification program.
The BIB® System, for example, consists of a silicone elastomer intragastric balloon that is inserted into the stomach and filled with fluid. Commercially available gastric balloons are filled with saline solution or air. The intragastric balloon functions by filling the stomach and enhancing appetite control. Placement of the intragastric balloon is non-surgical, usually requiring no more than 20-30 minutes. The procedure is performed gastroscopically in an outpatient setting, typically using local anesthesia and sedation. Placement is temporary, and intragastric balloons are typically removed after six months.
Most intragastric balloons utilized for this purpose are placed in the stomach in an empty or deflated state and thereafter filled (fully or partially) with a suitable fluid through a filler tube. The filler tube can be either removable or permanently attached to the balloon. The removable filler tube is typically attached prior to initial placement of the gastric balloon and then removed after inflation. The balloon occupies space in the stomach, thereby leaving less room available for food and creating a feeling of satiety for the overweight patient. Clinical results with these devices show that for many overweight patients, the intragastric balloons significantly help to control appetite and accomplish weight loss.
Among the intragastric balloons described in the prior art, one type remains connected to a filler tube during the entire period the balloon resides in the stomach. The balloon is introduced into the patient's stomach and a connected tube is extended through the nostril. Such an intragastric balloon is described, for example, in U.S. Pat. No. 4,133,315.
Another type of prior art intragastric balloon is placed into the stomach with the assistance of an appropriate plastic tube and usually a stylette. The balloon is filled with saline, whereafter the tube and stylette are withdrawn from the stomach. An intragastric balloon of this second type is described, for example, in UK Patent Application GB 2 090 747.
Even for the balloons of the second type, it may become desirable, from time-to-time, to add more fluid in order to further expand the balloon to optimize weight control. In addition, one means of removing the balloon is to deflate it by removing the saline from the balloon through a tube before the empty balloon is removed from the stomach.
To accomplish the foregoing, intragastric balloons of the second type are normally equipped with a self-sealing valve into which the filler tube and/or stylette can be inserted. One difficulty frequently encountered with this type of intragastric balloon is locating the valve when the balloon is already in the stomach and the surgeon attempts to reinsert the filler tube for the purpose of adding or removing fluid from the balloon.
Those skilled in the art will readily appreciate that manipulating the balloon while in situ to visually locate the valve is rather difficult, and the process of searching for the valve undesirably prolongs the procedure. Those experienced in the art will also readily appreciate that some intragastric balloons have been equipped with tabs for grasping the balloon for physical manipulation within the stomach and/or removal. For example, such tabs are shown in U.S. Pat. Nos. 5,084,061 and 6,746,460.
Even with the incorporation of such tabs into current intragastric balloon designs, the surgeon may still encounter significant difficulty in finding the valve for filling or removing fluid from the balloon. And even after the valve has been visually located, it is often still difficult or awkward for the surgeon to reinsert the filler tube into the example valve. The balloon may be slippery and positionally unstable. Additionally, spherical (or substantially spherical) intragastric balloons readily rotate in the stomach, so that even a slight disturbance of the balloon may place the filler valve into virtually any possible position relative to the filler tube poised to engage it.
Another problem associated with the heretofore known methods and devices is that following placement of the intragastric balloon, a patient may experience nausea from the interaction of the recently placed gastric balloon within the stomach. This has been particularly noted when the intragastric balloon is placed and filled to its capacity or substantially to its capacity in a single procedure.
Therefore, the present invention is directed at overcoming these problems associated with the prior art systems. These and other characteristics of the present invention will become apparent from the further disclosure to be made in the detailed description given below.